Hillary's Plan B

These days, Hillary Clinton has found herself a signature phrase. New York's junior senator has taken to describing Washington, D.C., as a kind of "evidence-free zone"a mantra she uses to slam the Bush administration for putting politics above science.

In May, she lamented those "who would like to turn Washington into an evidence-free zone," at a graduation upstate. By June, she was dishing out the expression to fans at a Manhattan fundraiser. On June 15, she offered the choice words again, this time as she hammered away at the "politicization of science by this administration" for the Senate record. "These days," she said in a submitted floor statement, "Washington often feels like an 'evidence-free zone,' where facts are only useful and necessary when they support your predetermined position."

If the idea has weighed on her mind lately, it was especially heavy that day. Clinton attended a June 15 hearing of the Senate Committee on Health, Education, Labor, and Pensions, where she, as a member, debated an issue that has come to epitomize the way the Bush White House allows the right to roll over reality.

The agenda centered on confirmation of President Bush's nominee to head the Food and Drug Administration, Lester Crawford, now acting commissioner. The committee would end up sending the nomination to the Senate, but not before Clinton and fellow senator Patty Murray, of Washington, had their say. Joined by Senator Barbara Mikulski, of Maryland, the Democratic women opposed Crawford because of his refusal to deal with emergency contraception, or Plan B. The FDA has failed to issue a decision on over-the-counter sales of Plan B for months now, despite having set a January deadline.

"What we are witnessing is the FDA . . . being run not on the basis of science, but on ideology," Clinton said in her statement, explaining to her colleagues that she and Murray were putting a "hold" on the Crawford nomination until the FDA rules on Plan B. Though they lost in committee, they can still stop a full vote from happening anytime soon.

The senators went public with their intention to block Crawford in April, after a closed-door meeting yielded no guarantee from the FDA to end the Plan B delay. It was the last straw for Clinton, who has been trying to extract a timeline from the agency. On March 17, she attempted to pin down a date during Crawford's confirmation hearing. His answer?

"I can't say for sure," he testified, "but I don't think it's going to be a long delay."

Three months later, Clinton made the hold official. "Our request is simple," she explained. "We want the FDA to make a decisionyes or no."

The move represents a carefully calculated strategy. Clinton isn't demanding that the FDA make Plan B over-the-counter, only that the agency resolve a matter derailed by religious conservatives. And in the process, she aims to expose the broader way politics gets in the way of science.

It's hard to pin the unusual delay over Plan B on anything but politics. The drug, better known as the morning-after pill,isn't revolutionary. It's a booster dose of progesterone, the hormone in a standard birth-control regimen.

As far back as the 1960s, doctors gave women who had unprotected sexwho suffered, say, a condom breakhigh doses of the regular pill within 72 hours to prevent unwanted pregnancy. Only in the last 10 years has a pharmaceutical company, Barr Laboratories, gotten the idea to market a single dose of progesterone for use after intercourse. In 1999, the FDA approved it as a prescription drug.

Recently, reproductive-rights advocates have embraced a Barr proposal to make Plan B available without a prescription. As it stands, the company's seeking a "behind the counter" label, meaning pharmacists could dispense it at their discretion to women under 18.

The idea of Plan B "sitting next to the toothpaste and the pencils," in the words of Wendy Wright, of Concerned Women for America, has gotten conservatives' attention. They're claiming the pill may prove dangerous. "Barr Labs hasn't done the studies to prove it's safe and effective for adolescents," says Wright, a senior policy director.

But the vast majority of medical experts say Plan B is safe, not least because birth-control pills have a well-established record themselves. Women can get Plan B without a prescription in 33 countries, and 70 scientific groups in this country endorse the switch to non-prescription status for all women, regardless of age.

In December 2003, two FDA scientific advisory panels, meeting jointly, recommended by a vote of 23 to four that the agency approve Plan B for non-prescription sales. They also agreed unanimously that the drug could be safely sold over the counter. One member touted the drug as the safest product reviewed in years.

That's when conservatives began makinga real fuss. Republican lawmakers sent a letter to the FDA emphasizing the purported risks to teens. And 49 wrote to Bush, urging the White House to get involved.

Four months later, in May, the FDA withheld approval. At the time, Steve Galson, the agency's acting director of the Center for Drug Evaluation and Research, acknowledged that he had ignored recommendations not only from the advisory panels, but also his own staff. In a letter to Barr, he wrote: "We have concluded that you have not provided adequate data to support a conclusion that Plan B can be used safely by young adolescent women."

"That told me right there this is political," says Kirsten Moore, of Reproductive Health Technologies Project.

Same goes for Senator Clinton, who, with 23 colleagues, requested that the Senate health committee hold hearings on the matter, to no avail. She and 16 senators also called on the General Accounting Office to investigate whether the decision "was based on politics rather than scientific evidence."

The delay on Barr's latest applicationwhich aims to resolve concerns about teen use of Plan Bhas only heightened the suspicions of FDA critics, as have reports that surfaced about one FDA panel member who'd voted against Plan B, David Hager, a Kentucky doctor known for trying to incorporate Christianity into medicine. In May, The Nation reported that Hager had boasted about his influence within the FDA during an October 2004 church sermon, letting it slip that he'd written a report for the agency to keep Plan B off drugstore shelves.

Clinton, in typical fashion, fired off a letter to Health and Human Services secretary Michael Leavitt, who oversees the FDA, calling again for an investigation.

"Day by day," Clinton wrote, with Murray, "the public's confidence in the FDA's ability to make decisions based on scientific evidence of safety and efficacy is eroding."

So will Clinton's hold on the Crawford nomination move the issue? Will the FDA approve what amounts to one of the safest forms of contraception around? "Eventually, yes, but not until there's a change in administration," predicts Sharon Camp, of the Alan Guttmacher Institute in Manhattan, who helped bring Plan B to this country and who sold the idea to Barr Labs.

The FDA remains silent about its decision. Spokesperson Suzanne Trevino says simply, "We don't comment on time frames for pending applications." And she refused to comment on any aspect of the hold.

Barr Labs, for its part, seems unsure of what's coming. On the one hand, says Jake Hanson, the company's chief lobbyist, "you can read all the pressure as a good thing that will encourage the FDA to support Plan B." On the other, he notes, "those opposed to the pill have dug in their heels," adding, "I doubt that Lester Crawford is the cause of the long delay."

Even staunch defenders of women's reproductive rights have failed to back the hold. Senator Edward Kennedy of Massachusetts serves as ranking Democrat on the Senate health committee. He has made plain that he believes the FDA is playing politics with Plan B. Still, he has effectively ignored his Democratic colleagues, voicing his support for Crawford at the June 15 meeting.

Surprisingly, the one factor working in Clinton's favor comes from Republicans. Last month, Senator Tom Coburn of Oklahoma announced that he, too, would be placing a hold on the Crawford nomination.

Coburn is a hardcore conservative, unlikely to support Plan B. Yet he disagrees with the FDA on other matters of sexuality. Today, according to Murray's office, Coburn's hold remains in effect until the agency issues new mandated labeling for condoms that would specify the limits of the contraceptive method. Meanwhile, two additional Republicans have chosen to block Crawford anonymously.

That the Republicans' unified front is cracking can only help Clinton and Murray. Senate Majority Leader Bill Frist could overturn their hold with 61 votes, yet he may let it lie, choosing instead to keep the GOP division quiet. "We suspect he doesn't want to have a big fight about this issue," says one Clinton aide, "especially since it's related to sex."

No matter what happens, it seems, Clinton has played her hand smartly. Reproductive-rights advocatessome of whom were questioning her loyalty after her famous appeal for common ground in a speech about abortion last January (see "God Is a Centrist Democrat," March 3, 2005)are now hailing her as "courageous," in the words of Nancy Keenan of NARAL Pro-Choice America. After all, advocates argue, the senator has kept one of the most important reproductive-rights issues in the spotlight. And she has put the White House on the defensive.

"It is outrageous that the Bush administration has ignored the science and has caved to the radical right on Plan B," Keenan says. So even if the tactic fails, she adds, " We'll be saying, 'See, you've just proven the senators right.' "